PDS is a permanent refillable eye implant, designed to provide continuous delivery of a customised ranibizumab formulation into the eye
Roche has unveiled the positive topline results from phase 3 Archway study, which evaluated Port Delivery System with ranibizumab (PDS) in people living with neovascular age-related macular degeneration (nAMD).
PDS is a permanent refillable eye implant, designed to be around the size of a rice grain, facilitates continuous delivery of a customised ranibizumab formulation into the eye, over a period of months.
Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor that binds to inhibit VEGF-A, a protein that plays crucial role in the formation of new blood vessels and the leakiness of the vessels.
Archway is a phase 3 clinical trial that evaluated the efficacy and safety of PDS
Archway is a randomised, multicentre, open-label phase 3 clinical trial that assessed the efficacy and safety of PDS, refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab.
The primary endpoint of the trial includes the change in best-corrected visual acuity (BCVA) score from baseline, while the secondary endpoints include safety, overall change in BCVA from baseline, and change from baseline in center point thickness over time.
Roche said that the Archway trial has reached its primary endpoint, confirming that patients who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab injections.
In addition to Archway, the Portal study is investigating the long-term safety and tolerability of PDS for the treatment of nAMD, and Pagoda trial for the treatment of diabetic macular edema (DME), a vision-threatening complication of diabetes.
The company has submitted the study results to health authorities around the world, including the US Food and Drug Administration and European Medicines Agency, seeking regulatory approval for the treatment of nAMD.
Roche global product development head and chief medical officer Levi Garraway said: “For people around the world receiving frequent eye injections for neovascular AMD, this continuous delivery system could greatly reduce their treatment burden.
“We look forward to presenting detailed Archway results at future medical meetings and discussing these data with regulatory authorities, with the aim of bringing this new treatment option to patients as soon as possible.”